Doripenem Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials evaluate the pharmacokinetic and pharmacodynamic profiles of doripenem across severe bacterial infections, including pediatric meningitis, community-acquired bacterial pneumonia, ventilator-associated pneumonia, and febrile neutropenia. Encompassing Phase I and Phase IV studies, these trials are sponsored by pharmaceutical leaders like Janssen Research & Development and academic institutions such as Michigan State University and Prince of Songkla University. Trial statuses range from completed pharmacodynamic assessments to terminated early-phase pediatric protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01366651	Terminated	Meningitis	Janssen Research & Development LLC	2012-03	Phase 1
NCT01524302	Completed	Pneumonia Bacterial\|Community-acquired	Gary E. Stein Pharm.D.\|Forest Laboratories\|Michigan State University	2012-02	Phase 4
NCT01467648	Completed	Ventilator-Associated Pneumonia	Sutep Jaruratanasirikul\|Prince of Songkla University	2010-10	Phase 4
NCT01401010	Completed	Febrile Neutropenia	Gary E. Stein Pharm.D.\|Michigan State University	2010-08	Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Doripenem product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Doripenem is a carbapenem antibiotic that covalently binds to essential penicillin-binding proteins, inhibiting transpeptidase-catalyzed peptidoglycan cross-linking and weakening bacterial cell wall architecture. This inhibition induces osmotic instability, cell lysis, and bacterial death, providing broad-spectrum bactericidal efficacy essential for treating clinical bacterial infections such as pneumonia, meningitis, and febrile neutropenia.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).